Study of Depemokimab Added to Standard Treatment for Adults Aged 40 to 80 With Moderate to Severe COPD and Type 2 Inflammation

What this Trial Is About

Researchers are evaluating depemokimab as an additional treatment for adults with moderate to severe chronic obstructive pulmonary disease COPD who have uncontrolled symptoms and type 2 inflammation. This Phase 3 study aims to assess the safety and effectiveness of depemokimab in reducing COPD flare-ups compared to a placebo, with the goal of improving patient outcomes. Participants will be randomly assigned to receive either depemokimab or a placebo alongside their standard COPD care. Depemokimab is given as a sterile liquid formulation, while the placebo is a sterile sodium chloride solution. The study is double-blind, meaning neither participants nor researchers know which treatment is given. Treatment and observation will continue for up to 104 weeks, allowing thorough assessment over two years. During the study, participants will undergo regular evaluations including lung function tests, symptom questionnaires like the COPD assessment test and St. Georges Respiratory Questionnaire, and monitoring of exacerbations requiring medical attention. Researchers will track the annual rate of moderate to severe COPD exacerbations as the primary outcome. Safety will be closely monitored throughout the trial, and participants health status will be reviewed periodically until study completion, which may last until August 2029.

Depemokimab as an Extended treatmeNt Duration Biologic in Adults With Chronic Obstructive Pulmonary Disease (COPD) and Type 2 Inflammation (ENDURA -1)